Application 212821

Type: ANDA
Sponsor: HUONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212821-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP		2020-05-07
A212821-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP		2023-06-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212821-001	AP
A212821-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212821-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212821-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212821-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212821-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212821-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212821-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212821-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212821-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212821-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212821-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212821-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212821-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212821-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212821-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212821-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212821-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212821-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212821-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212821-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212821-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212821-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212821-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212821-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212821-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212821-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212821-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212821-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212821-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212821-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212821-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212821-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212821-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212821-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212821-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212821-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212821-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212821-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212821-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212821-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212821-001	AP	1	`1c564ffb4f44…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Precision Dose, Inc.	27b6ef54-a093-2bef-e063-6394a90a7912	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Brookfield Pharmaceuticals, LLC.	e824ba5b-3289-5ad4-e053-2995a90acc20	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821 ndc (product): 71351-021
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC.	42531a38-7cff-de16-e063-6394a90a18d8	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Huons Co., Ltd.	8ec2d256-fc4f-44f6-bee2-eef2bf3bf580	2025-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821 ndc (product): 73293-0001
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Novagenix Labs LLC	7567ffb5-953a-4be9-9a02-c5a50dcd9306	2025-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	McKesson Corporation dba SKY Packaging	e1eabd6b-9bb8-646f-e053-2a95a90a7b83	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821 ndc (product): 63739-170

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63739-170	Lidocaine Hydrochloride	Lidocaine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-170	Lidocaine Hydrochloride	Lidocaine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
71351-021	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Brookfield Pharmaceuticals, LLC.	ANDA	Current
73293-0001	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Huons Co., Ltd.	ANDA	Current
73293-0001	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Huons Co., Ltd.	ANDA	Current
73293-0001	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Huons Co., Ltd.	ANDA	Current